MAUDE Adverse Event Report: C2 THERAPEUTICS INC. CRYOBALLOON ABLATION SYSTEM; CYROSURIGICAL UNIT WITH ACCESSORIES

Model Number	FG 1012 / FG 1009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data was downloaded from the controller and reviewed.One error for low balloon pressure was observed towards the end of the procedure, perhaps due to low cartridge refrigerant.However, no errors leading to any indication of perforations were identified.Seven (7) complete ablations were performed, all at normal operating pressures.The device performed as intended.
Event or Problem Description
C2 therapeutics became aware of a serious adverse event on (b)(6) 2017.- patient has a history of primary lung cancer with aggressive chemo radiation treatment.- successful cryoballoon treatment for squamous cell carcinoma in (b)(6) 2017.- on (b)(6) 2017 an emr was done to remove residual squamous ca.- on (b)(6) 2017 squamous ca was treated with cryoballoon for residual ca.Cryoballoon product performed as required.- perforation was noticed in the distal esophagus upon removal of the cryoballoon from the scope.- on (b)(6) 2017 at 3:30 pm the patient was doing fine.X-rays were negative for free air.Barium swallow test will be performed to evaluate stent effectiveness.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CYROSURIGICAL UNIT WITH ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS INC.; 303 convention way, suite 1; redwood city CA 94063
• MDR Report Key: 7051278
• Report Number: 3008780134-2017-00020
• Device Sequence Number: 13704155
• 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: K161202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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: Physician
• Device Expiration Date: 04/27/2018
• Device Model Number: FG 1012 / FG 1009
• Device Catalogue Number: FG 1012 / FG 1009
• Device Lot Number: 10252017-03 / 07262017-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1