BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6443314 · Received March 29, 2017

    Report

    Report Number
    3008780134-2017-00005
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 5, 2017
    Manufacturer
    C2 THERAPEUTICS, INC
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL/FOLLOW-UP REPORT FOR MDR 3008780134-2017-00005 BASED ON ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN. STRICTURE REPORTED BY THE PHYSICIAN AS DEFINITELY PROCEDURE-RELATED, AND POSSIBLY DEVICE-RELATED. STRICTURE (NARROWING OF THE ESOPHAGUS) IS A KNOWN POTENTIAL ADVERSE EVENT IN ENDOSCOPIC ABLATION THERAPY, AND MAY OCCUR REGARDLESS OF WHETHER OR NOT THERE IS A DEVICE MALFUNCTION. PATIENT SYMPTOMS RESOLVED AFTER STANDARD THERAPEUTIC INTERVENTION (TTS BALLOON DILATION). PER REQUEST FROM FDA ON 26MAR2020, SUPPLEMENTAL REPORT WAS SUBMITTED WITH INCORRECT REPORT NUMBER. THIS REPORT IS BEING SUBMITTED TO CORRECT THE REPORT NUMBER FROM 3008780134-2017-00021 TO 3008780134-2017-00005.

    Description of Event or Problem · 0

    C2 THERAPEUTICS BECAME AWARE OF STRICTURE ADVERSE EVENT ON (B)(6) 2017. INITIAL REPORT REFERENCED IN MDR 3008780134-2017-00005. ON (B)(6) 2017, A STRICTURE (SAME STRICTURE LOCATION AS REPORTED IN INITIAL REPORT) WAS OBSERVED AT 37 CM DURING FOLLOW-UP ENDOSCOPY (NO CRYOBALLOON PROCEDURE PERFORMED AT THIS TIME). DILATION WAS PERFORMED WITH CRE BALLOON DILATOR (NOT PART OF THE CRYOBALLOON SYSTEM) DUE TO EXISTING SCAR TISSUE.

    Additional Manufacturer Narrative · 1

    SERIOUS ADVERSE EVENT, LIKELY RELATED TO THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. FEEDBACK ANALYZED.

    Description of Event or Problem · 1

    (B)(6) 2017. STUDY PATIENT. FOLLOW-UP. THE PATIENT WAS HAVING DIFFICULTY SWALLOWING SOLID FOOD. HE HAS TO DRINK PLENTY OF WATER TO GET THE FOOD DOWN. THE ISSUE WAS DISCUSSED WITH THE PHYSICIAN. THE PATIENT HAD AN EGD ON (B)(6) 201 7 WHICH REVEALED ONE MODERATE, BENIGN INTRINSIC STENOSIS AT 36 CM. DILATION WAS PERFORMED ON (B)(6) 2017. PATIENT ALSO HAS LA GRADE A ESOPHAGITIS WITH NO BLEEDING AT THE GEJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224550 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH GEH C2 THERAPEUTICS, INC FG 1012/FG 1009 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention