MAUDE Adverse Event Report: C2 THERAPEUTICS, INC. CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH

Model Number	FG 1012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is a (b)(6) female with a history of squamous cell cancer of the esophagus and lung cancer.The patient had previous radiation treatment, a previous endoscopic mucosal resection (emr) in the mid esophagus as well as two previous cryoballoon ablation treatments.Patient underwent cryoablation procedure with the c2 cryoballoon ablation system on (b)(6) 2017.The physician sprayed lugol's solution diluted to 2% to identify the lesions; once identified he used a snare tip to coagulate mark the sites he was going to ablate.The first ablation was successful, but at the second ablation site (the more proximal lesion) the physician noticed a perforation that was 8 cm long by 5 mm wide.The physician successfully placed an esophageal stent then sutured to prevent migration.After checking with the patient in recovery the physician noted that the patient was doing fine and not in any pain.On (b)(6) 2017 during a conversation between c2 therapeutics and the physician, the physician noted that he was surprised at how fragile the esophagus was but he was not discouraged.He described the patient as being very sick with an extensive history of treatment including the 2 previous cryoballoon ablation treatments to treat 8 cm of disease as well as an emr, radiation and previous lung cancer; so cryoballoon treatment was this patient's only option.During a follow-up conversation between c2 therapeutics and the physician on 21 july 2017, the physician stated that the patient is doing well, that a gi series x ray was negative for any leak following placement of the esophageal stent and that the patient was starting a liquid diet and will likely be going home the next day.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH
• Manufacturer (Section D): C2 THERAPEUTICS, INC.; 303 convention way, ste 1; redwood city CA 94063
• MDR Report Key: 6804215
• Report Number: 3008780134-2017-00011
• Device Sequence Number: 1490229
• Product Code: GEH
• UDI-Device Identifier: 00854924006125
• UDI-Public: 0854924006125
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/20/2017

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: 12/23/2017
• Device Model Number: FG 1012
• Device Lot Number: 06222017-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/18/2017
• 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; Required Intervention
• Patient Age: 64 YR