MAUDE Adverse Event Report: PENTAX OF AMERICAS, INC. CRYOBALLOON ABLATION SYSTEM; GEN 2 CONTROLLER

Model Number	FG-1017
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Pentax medical was made aware of a complaint on (b)(6) 2022 that occurred in the operating room during use in the united states.Per the initial customer report, the physician advanced the balloon into a patient's esophagus, and automatically inflated balloon with the foot pedal, which resulted in a perforation of the esophagus, involving pentax medical c2 cryoballoon ablation system, focal standard catheter model fg-1028, used with cryoballoon controller model fg-1017 and cryoballoon foot pedal model fg-1018.Lot and serial numbers are unknown for all products.The patient was sent to surgery and underwent esophagectomy and repair of the perforation.The patient did well and was discharged home.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting: (b)(4).Pentax medical was notified of the (b)(6) 2022 event on (b)(6) 2022, weeks after the event occurred.The products had been reported as discarded prior to pentax medical being notified and were not available for evaluation.The controller and foot pedal are reuasable products and while they have not been returned for evaluation, follow up for the return of the devices is being performed so the investigation remains in-process.Since the serial and/or lot numbers of the devices wer not reported, a serial/lot history record reviews could not be completed for the products.If the products are returned and the serial and/or lot numbers become available, the history reviews will be completed.Mdr 3008780134-2022-00003 is being submitted for the pentax medical gen 2 focal standard catheter, model fg-1028, unknown lot number.Mdr 3008780134-2022-00005 is being submitted for the pentax medical gen 2 foot pedal, model fg-1018, unknown lot number.
Additional Manufacturer Narrative
Additional manufacturer narrative and corrected data: b4: updated date of this report with todays date.B5: added reference to refer to h10.G6: type of report updated.And updated h6: continued: international medical device regulators forum (imdrf).Adverse event reporting.Component code: remove: 819 foot pedal 819 foot pedal, 765 controller.Type of investigation: remove: 4118 type of investigation not yet determined, add: 4114 device not returned.Investigation findings: remove: 3233 results pending completion of investigation, add: 3221 no findings available.Investigation conclusions: remove: 11 conclusion not yet available, add: 4315 cause not established.The c2 cryoballoon ablation system is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of barrett's esophagus with dysplasia.Although covered by general indication the device is not cleared for specific use of squamous tissue.The physician chose to use this device on a medical condition covered under the general indication for the device.Although the patient injury was confirmed, since the devices were not returned or identified, there was no evaluation performed on the product and no indication the devices malfunctioned or failed to meet specification.Based on the investigation the exact cause of the user's experience during treatment remains was not established and remains unknown.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Mdr 3008780134-2022-00003 is being submitted for the pentax medical gen 2 focal standard catheter, model fg-1028, unknown lot number.Mdr is being submitted for the pentax medical gen 2 controller, model fg-1017, unknown serial number.Mdr 3008780134-2022-00005 is being submitted for the pentax medical gen 2 foot pedal, model fg-1018, unknown lot number.
Event or Problem Description
Refer to h10.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: GEN 2 CONTROLLER
• Manufacturer (Section D): PENTAX OF AMERICAS, INC.; 303 convention way; redwood city CA 90463
• Manufacturer (Section G): PENTAX OF AMERICAS, INC.; 303 convention way; redwood city CA 90463
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 14361674
• Report Number: 3008780134-2022-00004
• Device Sequence Number: 20050107
• Product Code: GEH
• UDI-Device Identifier: 00854924006170
• UDI-Public: 00854924006170
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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 Model Number: FG-1017
• Device Catalogue Number: FG-1017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG