MAUDE Adverse Event Report: C2 THERAPEUTICS, INC. CRYOBALLOON FOCAL ABLATION SYSTEM; CRYOSURGICAL UNIT, CRYOGENIC

Model Number FG 1012

Device Problem No Apparent Adverse Event (3189)

Patient Problem Scar Tissue (2060)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

The case on (b)(6) 2016 was performed without incident; there were no issues with devices, user, or patient.This event is being reported out an abundance of caution for possible effects from the previous ablation performed with a c2 cryoballoon device on (b)(6) 2016, although this initial case was also performed without any issues.

Event Description

On (b)(6) 2016, a male patient, age (b)(6), was treated for hiatal hernia=3cm.Case went well; there was no issue with a patient or device.During the case on (b)(6) 2016, the c2 company representative became aware of the additional information concerning a history of this patient: on (b)(6) 2016, the patient had his first barrett's treatment with the c2 cryoballoon ablation system, balloon cryotherapy, where 6 cm was treated with 16 ablations.There was no complication with this procedure.On (b)(6) 2016, the patient called the doctor due to dysphagia, admitting that he hadn't taken the carafate as prescribed.There was a stricture present.Doctor did tts balloon dilation (18-19-20 mm sizes).The c2 cryoballoon ablation system was not used in this procedure.C2 was unaware of this procedure until (b)(6) 2016.On (b)(6) 2016, the c2 cryoballoon ablation system treatment for hiatal hernia=3cm.Case went well.

• Brand Name: CRYOBALLOON FOCAL ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT, CRYOGENIC
• Manufacturer (Section D): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• Manufacturer (Section G): C2 THERAPEUTICS, INC.; 303 convention way; suite 1; redwood city CA 94063
• Manufacturer Contact: mladenka dominikovic ; 303 convention way; suite 1; redwood city, CA 94063 ; 6505034750
• MDR Report Key: 5817734
• MDR Text Key: 50293944
• Report Number: 3008780134-2016-00008
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2016

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
• Device Operator: Physician
• Device Expiration Date: 10/14/2016
• Device Model Number: FG 1012
• Device Lot Number: 04112016-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/22/2016
• Date Device Manufactured: 04/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR