MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON FOCAL ABLATION SYSTEM; CRYOSURGICAL UNIT AND ACCESSORIES.

Model Number	FG-1012
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) of Esophagus (2398)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pentax medical was made aware of a complaint on (b)(6) 2021 that occurred during use in the united states.The reported complaint was that the system preparation and balloon placement proceeded normally.Immediately upon initial puff inflation of the balloon, a large laceration and bleeding was observed, and the balloon was removed and the therapy was stopped.The procedure involved pentax medical c2 cryoballoon golf controller, model fg-1012, lot number 02012021-01, and cryoballoon focal ablation catheter model fg-1009, lot number 07092020-02.The physician spent a good amount of time inspecting the laceration and concluded that it was only to the muscle layer, not a full perforation.The physician did not clip or otherwise treat the laceration, just ensured the bleeding stopped and left it to heal on its own.Based on input from the pentax sales representative in the procedure room, the system did not appear to have malfunctioned, and no system faults were noted during the procedure.The physician concluded that whatever it was that was causing this patients mucosa to present barrett's in this unique way and allow for the easy denuding of the mucosa with radiofrequency ablation (rfa) also made the mucosa prone to laceration with balloon inflation.The pentax sales rep responded via email to a gfe on 03-mar-2021 stating that the procedure was for treatment purposes.The patient had an injury in the form of the reported mucosal tear and bleeding.There was no delay and no set date for further screening, although the patient will likely be brought back in 2 to 3 months.The patient information has not been provided at this time.The facility does follow all ifus and pre-procedural checks.The controller was returned to pentax medical and will be evaluated as part of the investigation.Although no failure of the pentax products were noted, since there was report of an serious injury this event is being reported.On 11-mar-2021, a lot history record(lhr) review for model fg-1009, lot number 07092020-02 was performed.The lhr review confirmed the device was manufactured on 16-jul-2020 and passed all required inspections, and was released accordingly.On 23-mar-2021, a lot history record(lhr) review for model fg-1012, lot number 02012021-01, serial (b)(4) was performed.The lhr review confirmed the device passed simulation testing and was inspected and tested on 03-feb-2021 and passed all acceptance requirements, and was released accordingly.The cryoballoon focal ablation handle/controller model fg-1012, lot #: sn (b)(4), l/n #02012021-01 was received at the pentax medical facility in (b)(4) for evaluation on 10-mar-2021.An investigation was performed on 11-mar-2021 to: examine controller to determine if event was related to cryoballoon performance.Specifically, performance related to balloon pressure; as over-inflation may present the possibility of esophageal laceration.The catheter cryoballoon focal ablation catheter model fg-1009, lot number 07092020-02 was not returned for evaluation as it was not returned for evaluation and was reported as being discarded.The controller's outer surface was cleaned, its data log was downloaded and graphed in microsoft excel.Data interpretation: first peak of pressure occurring at t = ~ 92s, ~2.25 psig is consistent with reported initial puff inflation.A lengthy period of device inactivity follows.The period of t=104s-114s is consistent with catheter deflation and removal.The pressure drops and a small peak, occurring at t=~108s, is consistent with squeezing out of remaining air in the partially-inflated balloon as it is pulled back through into the shaft of the endoscope.The period of t=114s to 150s, including peak at t=~132s is consistent with further external handling of the device.Comparison vs product specifications: several specifications are provided for pressure: per pdm 1012 (spec #22): "handle to allow balloon to pre-inflate to 1.25 to 2.5 psig".Per pdm 1012 (spec 6): "refrigerant flow automatically is stopped if balloon pressure exceeds 8.5 psig".Per sdm 1005 (as related to pdm 1012 spec #22): "handle to utilize the exhaust valve to prevent balloon pressure from exceeding 4.5 psig".Investigation conclusion: the device's initial puff pressure did not exceed specifications.The initial puff's pressure is far below the pressure limit of a treatment (4.5psig, per pdm 1012, spec #6, #7, and related sdm 1005 specs).At no time did the device's pressure ever exceed pressure specification limits.The device was found to be working as designed, and performing as intended.

• Brand Name: CRYOBALLOON FOCAL ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES.
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way; redwood city CA 90463
• MDR Report Key: 11562032
• Report Number: 3008780134-2021-00001
• Device Sequence Number: 16882996
• Product Code: GEH
• UDI-Device Identifier: 00854924006125
• UDI-Public: 00854924006125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: FG-1012
• Device Catalogue Number: FG-1012
• Device Lot Number: 02012021-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other