BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6804215 · Received August 18, 2017

    Report

    Report Number
    3008780134-2017-00011
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    July 20, 2017
    Report Date
    July 20, 2017
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    UDI-DI
    00854924006125
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585194 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH GEH C2 THERAPEUTICS, INC. FG 1012 06222017-01 00854924006125

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R