MAUDE Adverse Event Report: PENTAX MEDICAL CRYOBALLOON FOCAL ABLATION SYSTEM; GEN 2 FOCAL STANDARD CATHETER

Model Number	FG-1028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting (b)(4).These cases will be reported to the fda under the following mdr numbers: 3008780134-2021-00005_ pentax medical c2 cryoballoon golf controller, model fg-1017, lot number 0280.3008780134-2021-00006_ pentax medical c2 cryoballoon standard focal catheter, model fg-1028_unknown lot number.
Event or Problem Description
Pentax medical was made aware of a complaint on (b)(6) 2021 that occurred in the endoscopy suite during use in the united states.The reported complaint that the "balloon was inflated in the esophagus, resulting in a mucosal tear (not perforation).", involving pentax medical c2 cryoballoon controller, model fg-1017, serial number (b)(4), and pentax medical c2 cryoballoon standard focal catheter, model fg-1028, unknown lot number.The physician deployed three mucosal clips to address the tear and proceeded to treat the barrett's disease proximal to the clipped area with the standard focal catheter.The proximal treatment was completed as planned.The patient returned approximately 8 weeks later for a scheduled follow-up visit to assess his/her esophagus for barrett's disease.The patient reported significant pain for 6 weeks following the (b)(6) 2021 procedure and the physician decided to not proceed with further cryoballoon therapy with this patient.On (b)(6) 2021, a lot history record(lhr) review for pentax medical c2 cryoballoon controller, model fg-1017, serial number (b)(4) was performed.The lhr review confirmed the controller was manufactured on november 13, 2020 and released on january 25, 2021 after passing all required testing.The single use pentax medical c2 cryoballoon standard focal catheter was discarded by a virginia mason employee, and will not be available for evaluation.The pentax medical c2 cryoballoon controller, model fg-1017, serial number (b)(4) is not being returned for evaluation.Complaint investigation is in-process.

• Brand Name: CRYOBALLOON FOCAL ABLATION SYSTEM
• Common Device Name: GEN 2 FOCAL STANDARD CATHETER
• Manufacturer (Section D): PENTAX MEDICAL; 303 convention way; redwood city CA 90463
• MDR Report Key: 11787581
• Report Number: 3008780134-2021-00006
• Device Sequence Number: 17058725
• Product Code: GEH
• UDI-Device Identifier: 00854924006286
• UDI-Public: 00854924006286
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190194
• 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): 01/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG-1028
• Device Catalogue Number: FG-1028
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 05/06/2021
• 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